FDA.reportPublic FDA data

Application 219683

Type
NDA
Sponsor
JANSSEN BIOTECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INLEXZOGEMCITABINE HYDROCHLORIDESYSTEM;INTRAVESICALEQ 225MG BASEYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219683-001INLEXZOGEMCITABINE HYDROCHLORIDEEQ 225MG BASESYSTEM / INTRAVESICALRLD, RS2025-09-09

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219683-001124030862030-06-28Drug product2025-10-08
N219683-001125762532030-12-17Drug product2026-04-07
N219683-00186790942032-04-15Drug product2025-10-08
N219683-001107298232034-08-19Drug product2025-10-08
N219683-001124472412034-08-19Drug product2025-11-17
N219683-001126363002038-11-07U-45522026-06-24

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219683-001NP2028-09-09

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N219683-001INLEXZOEQ 225MG BASESYSTEM / INTRAVESICALRLD, RS2025-09-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219683-001INLEXZOEQ 225MG BASESYSTEM / INTRAVESICALRLD, RS2025-09-0931067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219683-001INLEXZOEQ 225MG BASESYSTEM / INTRAVESICALRLD, RS2025-09-09a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N219683-001124030862030-06-28Drug product2025-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219683-00186790942032-04-15Drug product2025-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219683-001107298232034-08-19Drug product2025-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219683-001124472412034-08-19Drug product2025-11-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219683-001124030862030-06-28Drug product2025-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219683-00186790942032-04-15Drug product2025-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219683-001107298232034-08-19Drug product2025-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219683-001124472412034-08-19Drug product2025-11-1731067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219683-001124030862030-06-28Drug product2025-10-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219683-001125762532030-12-17Drug product2026-04-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219683-00186790942032-04-15Drug product2025-10-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219683-001107298232034-08-19Drug product2025-10-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219683-001124472412034-08-19Drug product2025-11-17a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219683-001126363002038-11-07U-45522026-06-24a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N219683-001NP2028-09-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219683-001NP2028-09-0931067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219683-001NP2028-09-09a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INLEXZOGEMCITABINE INTRAVESICALJanssen Biotech, Inc3aef8dbc-34d0-4150-89f0-3b16cf0fbfdb2025-09-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 219683
application number: NDA219683

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85742ORIG 2026-04-24
83317ORIG 2025-09-11
83315ORIG 2025-09-10